Cord Blood Licensure, Part I
Program Code: 9204-QE-CT
Sunday, October 25, 2009
8:30 AM to 10:00 AM (ET)

MODERATOR
John D. McMannis, Ph.D., The University of Texas MD Anderson Cancer Center

SPEAKERS
Mary Beth Fisk, MT, CTBS, CQA, South Texas Blood & Tissue Center
Ellen F. Lazarus, MD, CAPT, USPHS, Food and Drug Adminstration
Liana Harvath, PhD, Liana Harvath, PhD, LLC

DESCRIPTION
A draft guidance document to assist public cord blood banks obtain a biologic license has been published by the FDA, with issuance of the final guidance expected shortly. The publication outlines a mechanism that facilities can use to apply for a cord blood license. AABB plans to hold a workshop in Bethesda, MD to inform facilities on what is required to submit a BLA once the Final Guidance is published. This session will provide some of the background of how far the CB regulations have progressed and what CBB can do today to prepare for publication of the Final Document.